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FDA 510(k)

SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

K-Number: K030782 · 2003-04-21

ApplicantW. L. Gore & Associates, Inc.
Decision Date2003-04-21
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2003-04-21 under 510(k) number K030782. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL?

SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL is a medical device that received FDA 510(k) clearance on 2003-04-21. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K030782.

When did SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL receive FDA 510(k) clearance?

SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL received FDA 510(k) clearance on 2003-04-21, under 510(k) number K030782.

Who is the listed applicant for SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL?

The FDA product code for SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL is FTM.

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Other records listing W. L. Gore & Associates, Inc. as applicant

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Related Devices (Code: FTM)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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